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Radiation Therapy
Pulsed Radiotherapy for Brain Cancer
N/A
Recruiting
Led By Jiayi Huang, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Females of childbearing potential (defined as a female who is non-menopausal or surgically sterilized) must be willing to use an acceptable method of birth control (i.e., hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
Karnofsky performance status (KPS) of at least 70%.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at approximately 3 months, 6 months, and 12 months after start of treatment
Awards & highlights
Study Summary
This trial looks at the side effects of a new type of radiation therapy for brain cancer. The new therapy is given in multiple small doses over time, instead of one large dose all at once.
Who is the study for?
This trial is for adults with IDH-mutant gliomas (brain tumors) who've had prior radiation. They should have a life expectancy of over a year, be able to consent, and women must use birth control. It's not for pregnant individuals or those with certain medical conditions that conflict with the treatment.Check my eligibility
What is being tested?
The study tests TMPRT, a type of radiotherapy given in small doses at set intervals to potentially increase effectiveness and reduce side effects compared to one large dose. The focus is on patients who've previously received brain radiation therapy.See study design
What are the potential side effects?
While specific side effects are not listed, TMPRT aims to minimize toxicity compared to traditional radiation therapy. Potential general side effects may include skin irritation, fatigue, headaches, nausea, and neurological symptoms.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using or willing to use birth control during the study.
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I am able to care for myself but may not be able to do active work.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of treatment through 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of treatment through 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cumulative incidence of grade 3 or higher reirradiation-related central nervous system adverse events
Frequency of acute intolerable toxicities
Secondary outcome measures
Change in interference as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
Change in quality of life (QOL) as measured by self-reported QOL on the Linear Analog Scale Assessment (LASA)
Change in symptom burden as measured by M.D. Anderson Symptom Inventory - Brain Tumor (MDASI-BT)
+3 moreOther outcome measures
Relative changes of different subtypes of circulating T-cells
Relative changes of different subtypes of myeloid cells
Trial Design
1Treatment groups
Experimental Treatment
Group I: Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)Experimental Treatment1 Intervention
Patients receive TMPRT daily as 10 pulses of 0.2 Gy each with a 3-minute interval between pulses (effective dose rate = 0.0667 Gy/min) to a total dose of 54 Gy at 2 Gy per day. Treatment continues for a total of 27 fractions in the absence of disease progression or unacceptable toxicity.
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Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,935 Previous Clinical Trials
2,299,861 Total Patients Enrolled
Jiayi Huang, M.D.Principal InvestigatorWashington University School of Medicine
6 Previous Clinical Trials
202 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had targeted radiation to the same area before, but the total dose was under 75 Gy and it was over 6 months ago.You are currently pregnant.I am using or willing to use birth control during the study.I had external beam radiation therapy over 2 years ago.I can understand and am willing to sign the consent form.I am not using bevacizumab or similar drugs for my treatment.My cancer has spread to the lining of my brain or other parts of my body.My previous radiation therapy was between 45 and 75 Gy.I cannot have an MRI due to a medical condition or implant.My brain tumor has returned, has IDH mutation, and was previously treated with radiation.I am able to care for myself but may not be able to do active work.I have had severe tissue damage from radiation therapy before.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1: temporally-modulated pulsed radiotherapy (TMPRT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals can be involved in this trial at maximum capacity?
"Affirmative. According to the data on clinicaltrials.gov, this investigation has been open for recruitment since June 28th 2022 and was recently updated October 25th 2022. The study is searching for 12 individuals at a single medical centre."
Answered by AI
Is this research endeavor still accepting volunteers?
"This clinical trial is actively enrolling participants, as indicated on the clinicaltrials.gov website. The study's first posting was June 28th 2022 while its most recent update came October 25th of that same year."
Answered by AI
What is the principal purpose behind this clinical experiment?
"This clinical trial has a 3-month time frame and will measure the Cumulative incidence of grade 3 or higher reirradiation-related central nervous system adverse events as its primary outcome. Secondary endpoints include Change in interference (as measured by MDASI-BT), Change in Quality of Life (QOL; assessed with LASA) and Relative changes of different subtypes of circulating T-cells, which are determined from blood samples collected prior to the start of treatment and at week 6 after radiation therapy."
Answered by AI
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